Adjustable suture button construct

ABSTRACT

An adjustable construct for fixation of a tendon or ligament graft in a tunnel. The construct comprises a flexible, adjustable loop connected to tissue (for example, graft, ligament or tendon). The adjustable loop may be integrated with an additional tissue supporting device (for example, a wedge or a plug). The tissue is secured within a bone socket/tunnel by adjusting the length of the flexible adjustable loop.

CROSS-REFERENCE TO RELATED APPLICATIONS

This is a divisional of application Ser. No. 12/751,835, filed Mar. 31,2010, now U.S. Pat. No. 8,460,379, which claims the benefit of U.S.Provisional Application No. 61/165,343, filed Mar. 31, 2009, U.S.Provisional Application No. 61/168,117, filed Apr. 9, 2009, U.S.Provisional Application No. 61/259,507, filed Nov. 9, 2009, U.S.Provisional Patent Application No. 61/311,234, filed Mar. 5, 2010, andU.S. Provisional Patent Application No. 61/311,211, filed Mar. 5, 2010,the entire disclosures of which are incorporated by reference herein.

FIELD OF THE INVENTION

The present invention relates to the field of surgery reconstructionand, more particularly, to joint or ligament reconstruction techniquesand associated fixation and reconstruction devices.

BACKGROUND OF THE INVENTION

Reconstructive surgeries, particularly anterior cruciate ligament (ACL)reconstruction, are well-known in the art. Methods of ACL reconstructionusing interference screw fixation are described, for example, in U.S.Pat. Nos. 5,211,647 and 5,320,626. In general, these methods oftenodesis involve drilling a tunnel through the tibia, drilling a closedtunnel (socket) into the femur, inserting a substitute ACL graft intothe tunnels, and securing the grafts to the walls of the tibial andfemoral tunnels using interference screws or the like.

Fixation of the graft (for example, a semitendonosus allograft) withinthe two knee sockets (i.e., the femoral and tibial tunnels or sockets)requires determination of the proper graft length (soft tissue graft orBTB graft) which in turn is calculated based on the entire length of thesockets plus the intraarticular space between them. Proper determinationof the graft length ensures accurate placement of the graft within thefemoral and tibial tunnels (sockets).

The devices and methods of ligament reconstruction of the presentinvention provide alternative fixation techniques that employ at leastone button with an adjustable suture loop attached to soft tissue, graftor ligament, for improved fixation and exact determination of the graftlength within the bone sockets.

SUMMARY OF THE INVENTION

The present invention provides techniques and reconstruction systems forfixation of bone to bone, or soft tissue to bone. The reconstructionsystem of the present invention comprises at least one button/loopconstruct with a flexible, adjustable loop connected to tissue (such assoft tissue, graft, tendon, ligament, synthetic material, biologicalmaterial, bone, or combinations of such materials, among others). Thetissue may be directly looped over the flexible, adjustable loop forinsertion and fixation into a bone tunnel or socket. Alternatively, thetissue may be looped over a tissue supporting device (such as a wedge,for example) that is connected to the flexible, adjustable loop of thebutton/loop construct for insertion and fixation into a bone tunnel orsocket.

The button/loop construct has an adjustable loop length that allowsadjustment in one direction while preventing or locking the constructfrom loosening in the opposite direction, due to applied tensile forces.The adjustable loop facilitates graft fixation by not requiringcalculation of the proper transosseous distance in advance. If a graftsupporting device (such as a wedge, for example) is employed, the graftsupporting device occludes the socket/tunnel to prevent fluidextravasation and minimizes micromotion of the graft at the boneorifice/graft interface which may lead to tunnel widening. The graftsupporting device also provides for both cortical fixation andsocket/tunnel compression of the graft or ligament.

The present invention also provides methods of fixation of bone to bone,or soft tissue to bone. An exemplary method of the present inventioncomprises the steps of: (i) providing a bone tunnel; (ii) providing abutton/graft construct including a button and a loop of flexiblematerial having an adjustable length, in the vicinity of the bonetunnel; (iii) looping tissue (graft) over the adjustable loop; (iv)advancing the button/graft construct with the looped tissue through thebone tunnel; and (v) securing the tissue within the bone tunnel byadjusting the length of the adjustable loop.

These and other features and advantages of the invention will be moreapparent from the following detailed description that is provided inconnection with the accompanying drawing and illustrated exemplaryembodiments of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1-3 illustrate various view of a button/loop construct with aflexible, adjustable loop according to the present invention (showingthe splicing marked with blue and green colors for easy identification).

FIGS. 3(a)-(g) illustrate exemplary steps of forming/assembling thebutton/loop construct with a flexible, adjustable loop of FIGS. 1-3(without a graft supporting device).

FIGS. 3(h) and 3(i) illustrate a side view and a bottom view,respectively, of an exemplary one-hole button employed in thebutton/loop construct with a flexible, adjustable loop of the presentinvention.

FIG. 4 illustrates a side view of the adjustable button/loop constructof FIGS. 1-3 integrated with a graft supporting device (for example, awedge) according to a first embodiment of the present invention.

FIG. 5 illustrates a perspective view of the assembly of FIG. 4.

FIG. 6 illustrates a partial, cross-sectional view of the wedge of theassembly of FIG. 5, showing how the suture construct sits in the wedge.

FIGS. 6(a)-(g) illustrate exemplary steps of forming/assembling thebutton/loop construct with a flexible, adjustable loop (a four-pointknotless fixation device and locking mechanism) and with a graftsupporting device of FIGS. 4 and 5.

FIG. 7 illustrates a perspective view of the adjustable button/loopconstruct of FIGS. 1-3 integrated with another graft supporting device(for example, a trapezoidal wedge) according to a second embodiment ofthe present invention.

FIG. 8 illustrates a perspective view of the adjustable button/loopconstruct of FIGS. 1-3 integrated with another graft supporting device(for example, an expanding plug) according to a third embodiment of thepresent invention.

FIG. 9 illustrates the assembly of FIG. 4 (including an adjustablebutton/loop construct with a graft supporting device) and furtherprovided with tissue (a graft or ligament, for example) looped over thegraft supporting device.

FIGS. 10-17 illustrate subsequent steps of a method of tissuereconstruction according to an embodiment of the present invention andemploying the assembly of FIG. 9.

FIG. 18 illustrates a driver securing the assembly of FIG. 9 within afemoral tunnel or socket.

FIG. 19 illustrates the assembly of FIG. 9 secured within both thefemoral tunnel and the tibial tunnel.

FIGS. 20-40 illustrate subsequent steps of a method of ACLreconstruction according to another embodiment of the present inventionand employing the button/loop construct with a flexible, adjustable loopof FIGS. 1-3.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The present invention provides fixation techniques that employ anadjustable suture loop that supports tissue (such as graft or ligament)for improved fixation and elimination for the need to calculate theexact transosseous distance for each bone.

The reconstruction system of the present invention comprises abutton/loop construct with a flexible, adjustable loop connected totissue (for example, soft tissue, graft, tendon, ligament, syntheticmaterial, bone, or combinations of such materials, among others). Thetissue may be directly looped over the flexible, adjustable loop forinsertion into a bone tunnel or socket. Alternatively, the tissue may belooped over a tissue supporting device (such as a wedge, for example)that is connected to the flexible, adjustable loop for further insertioninto a bone tunnel or socket.

The tissue supporting device may or may not incorporate a drive socketfor attachment of instrumentation to facilitate orientation oradvancement of the device. The adjustable self-locking constructfacilitates graft fixation by not necessitating calculation of theproper graft length in advance. The adjustable self-locking constructalso provides for both cortical fixation and socket/tunnel compressionof the graft or ligament. The tissue supporting device (e.g., the wedge,implant, anchor or plug) also occludes the socket/tunnel to preventfluid extravasation and minimizes micromotion of the tissue (graft) atthe bone orifice/graft interface which may lead to tunnel widening.

The present invention also provides a method of ACL fixation. The methodof the present invention comprises the steps of: (i) forming a bonetunnel; (ii) providing a button/graft construct including a button and aloop of flexible material, the loop having an adjustable length; (iii)looping tissue (such as graft or tendon) over the adjustable loop; (iv)advancing the button/graft construct with the looped graft through thebone tunnel; and (v) securing the tissue (graft or tendon) within thebone tunnel by adjusting the length of the adjustable loop.

Referring now to the drawings, where like elements are designated bylike reference numerals, FIGS. 1-40 illustrate various components offinal assembly 100, 200 of the present invention comprising at least oneself-locking adjustable button/loop construct 10 which allows a graft 80to be fully inserted and seated in femoral and tibial tunnels. The graftmay be looped over a graft supporting device 30 (such as a wedge,anchor, or plug), and then inserted and secured within the bone tunnel(as shown in FIGS. 9-19, which illustrate assembly 100 with graft 80looped over graft supporting device 30 which is attached to adjustableconstruct 10). Alternatively, the graft may be directly looped throughthe adjustable loop of the button/loop construct 10 and then insertedand secured within the bone tunnel (as shown in FIGS. 20-40, whichillustrate assembly 200 with graft 80 looped directly through theadjustable loop of adjustable construct 10).

FIGS. 1-3 illustrate a button/loop construct 10 of the present inventioncomprising a flexible, adjustable loop 3 connected to a button 20. Thebutton provides cortical bone fixation of the graft. The loop has anadjustable length (with an adjustable perimeter) and, as describedbelow, may be connected to a tissue supporting device (a wedge) that, inturn, supports tissue (such as a graft or ligament) or may be in directcontact with the tissue. The button/loop construct 10 of the presentinvention (shown in FIG. 1) is a strong locking mechanism (a four-pointknotless locking mechanism) that resists slippage and offers strongerpull-to-failure than anatomical failure load. Specifically, inaccordance with the present invention, a graft 80 is looped through theadjustable loop and then pulled into the bone tunnel or, alternatively,is looped over the wedge 30 and positioned within a bone tunnel using adriver which is received in a socket 36 of wedge 30.

Details regarding the formation/assembly of the self-locking adjustableconstruct 10 (which allows a graft to be fully inserted and seated in abone tunnel) are provided in U.S. Provisional Patent Application No.61/259,507 (filed on Nov. 9, 2009) and U.S. Provisional PatentApplication No. 61/311,234 (filed on Mar. 5, 2010), the disclosures ofwhich are incorporated by reference in their entirety herewith.

As described in U.S. Provisional Patent Application Nos. 61/259,507 and61/311,234, a self-locking adjustable knotless construct (such asconstruct 10 of FIG. 1) consists of button 20 and flexible material 1with two adjustable eyesplices 2 that are interconnected to form oneadjustable loop 3. By pulling on the free braid strands 1, theindividual eyesplices 2 constrict and, in turn, reduce the loop length L(FIG. 4) of loop 3. In order for loop 3 to elongate, a force needs to beapplied interior to one or both of the eyesplices 2 to elongate theindividual loops.

The loop construct 10 of the present invention advantageously (i)eliminates the need to calculate loop length for a loop and buttoncortical soft tissue fixation anchor; (ii) allows graft tensioning afterfemoral and tibial fixation have been achieved; (iii) allowsself-locking with no surgical knots required; (iv) allows a graft to befully inserted into a bone tunnel; and (v) eliminates button flippingdifficulties in similar fixed loop length fixation systems.

Loop construct 10 comprises two independently-formed and interconnectedloops 2, each of the loops 2 having an adjustable length relative toeach other. The construct allows adjustment in one direction whilepreventing or locking the construct 10 from loosening in the oppositedirection, due to applied tensile forces.

Flexible strand (braid) 1 is first passed through the button 20 and thestrands of the braid are looped around one another. Each end of thebraid is spliced through itself, traveling in the direction back towardsthe original hole passed through in button 20. Each end of the braid ispassed through the opposite button hole and down towards interconnectedbraid loops 2. The final construct 10 with eyesplice interconnection 22is shown in FIG. 1.

The construct 10 of the present invention advantageously allows unwantedconstriction of the loop to be easily reversed when braid strands arepulled in a systematic way; the design also minimizes loop elongationduring cyclic loading and supports ultimate loads well above what couldbe expected when implanted in a patient.

FIG. 3 illustrates another depiction of the button/loop construct 10 ofthe present invention. As noted above, the button/loop construct 10consists of two adjustable eyesplices (2) that are interconnected toform one adjustable loop (3). By pulling on the free braid strands (1),the individual eyesplices (2) constrict and, in turn, reduce the looplength of loop (3). In order for loop (3) to elongate, a force needs tobe applied interior to one or both of the eyesplices (2) to elongate theindividual loops. In a button/loop graft fixation device, the graftwould be loaded through loop (3). This method of loading places the loadinterior to loop (3) but exterior to the individual eyesplices (2),deflecting the load away from either of the adjustable eyesplicespreventing their elongation and, thus, preventing elongation of loop(3). This is the basis for the self-locking function.

Exemplary steps of a method of forming/assembling construct 10 of FIGS.1-3 are detailed in both U.S. Provisional Patent Application Nos.61/259,507 (filed on Nov. 9, 2009) and 61/311,234 (filed on Mar. 5,2010), and they include as starting materials a suture strand 1 (forexample, 50 inches of braided UHMWPE strand); a suture passing device 8such as a needle 8 (for example, a blunt tip needle with nitinol loop)and a button 20 (for example, a 3.5 mm titanium button). Exemplary stepsof forming/assembling the button/loop construct 10 with a flexible,adjustable loop of FIGS. 1-3 (i.e., the wedgeless device) areillustrated in FIGS. 3(a)-(g) and are detailed below.

FIG. 3(a) illustrates exemplary starting materials: a suture strand 1(for example, 50 inches of braided UHMWPE strand); a suture passingdevice 8 such as a needle 8 (for example, a blunt tip needle withnitinol loop) and a button 20 (for example, a 3.5 mm titanium button).

The suture strand 1 is folded to create two equal length parallel braidstrands (FIG. 3(b)). At this step, the braid 1 is folded at themidpoint, 25 inches, to create two parallel equal length braid strands(Step 1). At Step 2 (FIG. 3(c)), a first eyesplice 2 is created on thefirst strand of braid by passing the blunt tip needle through the centerof the braid with the end of the braid being carried through in thenitinol loop of the needle. The splice should travel for a distance ofabout 17-19 mm through the braid towards the braid midpoint created in(Step 1) (FIG. 3(d)).

Once the first eyesplice 2 has been formed, at Step 3, the button 20 isslid over the non-spliced strand passing the strand through both buttonholes (FIG. 3(e)). The button is slid so that it rests over the firstspliced section. At Step 4, a second eyesplice 2 is formed, similar tothe first one, with the opposing strand (FIG. 3(f)). The strand shouldbe looped through the first eyesplice loop resulting in two eyespliceloops that are interconnected. Again, the splice length should bebetween 17-19 mm. The splice should be created such that the exitingaperture of the splice is as close as possible to the first eyesplice.

At Step 5, once the free end has created the eyesplice, pass it throughboth holes of the button and slide the button to center between the twoeyesplice sections (FIG. 3(g)). The result is one overall adjustableloop 3 that is comprised of the interconnected adjustable eyespliceloops 2 (FIG. 3(g)).

FIG. 1 illustrates free strands 1 of the self-locking adjustableconstruct 10 pulled back through the button 20 to expose the spliceexits points 3 a, 3 b. Also shown in FIG. 1 are two splice entrancepoints 2 a, 2 b. FIG. 2 shows the button 20 adjusted downward to givefull view of the two splice entrance points 2 a, 2 b and the two spliceexit points 3 a, 3 b. FIG. 3 illustrates the final self-lockingadjustable construct 10 with no additional splicing occurring and withthe free strands 1 passed through the opposite button holes of thebutton 20.

The button 20 may be formed, for example, of metal, PEEK or PLLA. Theflexible material 1 may be suture such as a suture braid with braidedfilaments having a hollow core (for example, strands of suture such asultrahigh molecular weight polyethylene (UHMWPE) braided with strands ofpolyester, collagen, or other suture materials, such as PET, PEEK, silknylon, and absorbable polymers, among many others). The flexiblematerial 1 may also contain a bioabsorbable material, such as PLLA orone of the other polylactides, for example, and/or may be formed oftwisted fibers having strands of a contrasting color added to thebraided threads, to make the suture more visible during surgicalprocedures. In exemplary embodiments, flexible material 1 may be abraided suture cover containing strands of a high strength suturematerial, such as FiberWire® suture, sold by Arthrex, Inc. of Naples,Fla. If desired, the flexible material 1 may be coated (partially ortotally) with wax (beeswax, petroleum wax, polyethylene wax, or others),silicone (Dow Corning silicone fluid 202A or others), silicone rubbers(Nusil Med 2245, Nusil Med 2174 with a bonding catalyst, or others) PTFE(Teflon, Hostaflon, or others), PBA (polybutylate acid), ethyl cellulose(Filodel) or other coatings, to improve lubricity of the braid, knotsecurity, pliability, handleability or abrasion resistance, for example.

Details of button 20 are set forth in U.S. Patent Publ. No. 2007/0179531(Thornes), the disclosure of which is also incorporated by reference inits entirety herewith. As detailed in U.S. Patent Publ. No.2007/0179531, the button 20 is provided with at least one opening thatallows the passage of the flexible material 1 to pass thereto. Thebutton may be round or oblong and may be provided with one or moreapertures. An exemplary and illustrative embodiment of a button 29 thatmay be employed in the self-locking adjustable construct 10 of thepresent invention (in both the wedge and the wedgeless embodiments) isillustrated in FIGS. 3(h) and 3(i). Button 29 is a one-hole buttoncomprising an oval body 23 with a first or top surface 23 a and a secondor bottom surface 23 b opposite to the first or top surface 23 a. Aplurality of apertures 25 are provided within the body 23 and athrough-hole 28 extends within the body 23. The through-hole 28 isadjacent the bottom surface 23 b, and communicates with the apertures25. In this manner, the flexible material 1 may be passed through theone hole 28 of the button 29 during the formation/assembling of theself-locking adjustable construct 10 of the present invention.

FIGS. 4-6 illustrate the construct of FIG. 1 with a graft supportingdevice 30 attached thereto. The graft supporting device may be a wedge,an anchor, a plug or an implant, among others. If a wedge is employed,the wedge 30 may have a trapezoidal shape (as shown in FIGS. 4-7) orsimilar shapes, and is provided with a plurality of transversal passagesor through holes 31, 33 (FIGS. 4-6) that allow flexible strand 1 ofconstruct 10 to pass therethrough. Opening 36 (FIGS. 5 and 6) is alsoprovided at a most distal end of the wedge 30 to receive a correspondingend of a driver.

Details of a method of attaching the self-locking adjustable construct10 of FIGS. 1-3 to graft supporting device 30 (for example, a wedge 30)to form assembly 50 are set forth in U.S. Provisional Patent ApplicationNo. 61/311,211 (filed on Mar. 5, 2010), the disclosure of which isincorporated by reference herewith in its entirety. As detailed in U.S.Provisional Patent Application No. 61/311,211, the eyesplice is passedthrough the proximal hole 31 of the wedge 30. After the formation of thesecond eyesplice, the wedge 30 is positioned between the button 20 (orbutton 29) and eyesplice interconnection 22 (FIG. 1). Once the free endhas created the eyesplice, it is passed through both holes of the buttonand the button is slid to center between the two eyesplice sections. Theresult is one overall adjustable loop that is comprised of theinterconnected adjustable eyesplice loops. For the wedge assembly, theassembly is finished by moving the wedge 30 such that the wedge ispositioned over the eyesplice interconnection 22 and the free braidstrands 1 are passed through the side holes of the wedge and out of thedistal opening 36 (distal hex socket) of wedge 30.

FIGS. 6(a)-(g) illustrate exemplary steps (Steps 1-7) offorming/assembling assembly 50 having the button/loop construct with aflexible, adjustable loop (a four-point knotless fixation device andlocking mechanism) and the graft supporting device 30 of FIGS. 4 and 5.

FIG. 6(a) illustrates starting materials: suture strand 1 (for example,50 inches of braided UHMWPE strand); a suture passing device such as aneedle 8 (for example, a blunt tip needle with nitinol loop); a button20, 29 (for example, a 3.5 mm titanium button); and a wedge 30 (forexample, a PEEK femoral wedge for wedge assemblies).

FIG. 6(b) illustrates the suture strand 1 folded to create two equallength parallel braid strands. At this step, the braid 1 is folded atthe midpoint, 25 inches, to create two parallel equal length braidstrands (Step 1).

FIG. 6(c) shows the measurement of the eyesplice. At this step (Step 2),an eyesplice 2 is created on the first strand of braid 1 by passing theblunt tip needle 8 through the center of the braid 1 with the end of thebraid being carried through in the nitinol loop of the needle 8. Thesplice should travel for a distance of about 17-19 mm through the braidtowards the braid midpoint created in Step 1.

FIG. 6(d) shows the braid carried though the splice 1 with the nitinolloop needle 8.

FIG. 6(e) shows the formation of the first eyesplice 2. Step 3: thebutton is slid over the non-spliced strand passing the strand throughboth button holes. Also pass the free strand that results from theeyesplice through the button holes. Slide the button so that it restsover the first spliced section. For the wedge assembly, additionally,pass the eyesplice through the proximal hole of the wedge.

FIG. 6(f) shows the formation of the second eyesplice. Step 4: createanother eyesplice 2 similar to the first one, with the opposing strand.The strand should be looped through the first eyesplice loop resultingin two eyesplice loops that are interconnected. Again, the splice lengthshould be between 17-19 mm. The splice should be created such that theexiting aperture of the splice is as close as possible to the firsteyesplice. On wedge assembling, the wedge 30 should be positionedbetween the button 20 and eyesplice interconnection 22 as shown in FIG.6(f).

FIG. 6(g) shows the final braid construct assembly 50. Step 5: once thefree end has created the eyesplice, pass it through both holes of thebutton 20 and slide the button to center between the two eyesplicesections 2. The result is one overall adjustable loop 3 that iscomprised of the interconnected adjustable eyesplice loops 2. For thewedge assembly, finish the assembly by moving the wedge 30 such that ispositioned over the eyesplice interconnection 22 and pass the free braidstrands through the side holes of the wedge and out of the distal hex.

Step 6: After the loop is constructed, the loop may be stretched forapproximately 30 seconds at 50 LBF. The force to stretch the loop ispreferably applied such that it acts on the overall loop created betweenthe two eyesplices rather than either individual eyesplice loop.

Step 7: Place passing suture through button hole and pull until strandsare equal length.

FIGS. 7 and 8 illustrate assemblies 50 a, 50 b including theself-locking adjustable construct 10 of FIGS. 1-3 attached to othergraft supporting devices such as supporting device 30 a (FIG. 7) or plug30 b (FIG. 8) which are similar to the graft supporting device 30. Asdetailed below, supporting devices 30, 30 a, 30 b are employed forpreparing and securing soft tissue, graft or ligament within bonetunnels, according to embodiments of the present invention. Inadditional embodiments, some of the supporting devices may be alsoprovided with fixation features (such as threads, ridges, or expandingtabs, for example) to aid in the fixation of the tissue (graft orligament) within the bone tunnel or socket. For example, a graftsupporting device which may also act as a fixation device is plug 30 b,which may be an expanding plug, the details of which are set forth inU.S. Patent Publ. No. 2008/0275554, the disclosure of which isincorporated by reference in its entirety herewith.

FIGS. 9-19 illustrate assembly 100 (button/wedge/adjustable loopassembly 100) comprising a self-locking adjustable knotless construct 10(formed of button 20 and two adjustable eyesplices (2) that areinterconnected to form one adjustable loop (3)) and a graft supportingdevice 30 (for example, a femoral wedge 30) with tissue 80 (graft,tendon, ligament, synthetic material, biologic material, bone, orcombinations of such materials) attached thereto. The flexible loop ofthe self-locking adjustable knotless construct 10 is connected to graftsupporting device 30. FIG. 19 illustrates final assembly 100 of thepresent invention positioned within the femoral and tibialsockets/tunnels and according to a method of ACL reconstruction of thepresent invention.

As shown in FIG. 9, tissue (graft) 80 is placed through the open loop ofthe self-locking adjustable knotless construct 10 and rests over thewedge “saddle” 30. The tissue 80 may be a ligament graft such asautograft, allograft or artificial graft. The loop is connected tobutton 20 and to the graft supporting device 30.

The graft supporting device 30 shown in FIGS. 6 and 9 has a proximal end32 and a distal end 34. In an exemplary embodiment, the proximal end 32is shaped like a saddle and the distal end 34 is shaped like acylindrical plug. The proximal end 32 contacts the graft 80 and has ashape and surface suitable for protecting the graft. The distal end 34separates the graft bundle and compresses the graft 80 against the wallsof the tunnel or socket after insertion providing additional fixation.The outer surface of the distal end 34 may have additional features 39such as threads, ridges, or expanding tabs (FIG. 9) designed to aid infixation. One skilled in the art will recognize that many shapes andsurface features will aid in protecting the graft and provide additionalfixation.

The graft supporting device 30 also includes a passageway 31 forconnecting to the flexible loop. Additionally, the graft supportingdevice 30 may be provided with a second passageway 33 for connecting tothe ends of the flexible loop. Second passageway 33 may connect toopening 36 extending from the distal end 34 of the graft supportingdevice 30. Opening 36 provides a channel for the ends 1 a, 1 b (FIG. 6)of the flexible loop to extend out from the surgical site for adjustingthe tension and size of the loop. Opening 36 may also be shaped to matewith an insertion instrument (for example, a driver).

The reconstruction system 100 may be provided as pre-assembled and/orpre-packaged to the surgeon, or may be assembled by the surgeon duringthe surgery. If the surgeon is using an autograft, after the surgeonharvests the graft, the graft 80 is attached to the reconstructionsystem 100 by sliding the graft through the loop 3 and over the proximalend 32 of the graft supporting device 30. The entire reconstructionsystem is ready for implantation once the graft has been looped over thegraft supporting device. If desired, the graft 80 may be secured to thegraft supporting device with sutures, for example.

FIGS. 10-17 illustrate various steps of a method of preparing andinserting the reconstruction system 100 of FIG. 9 to bone 15, accordingto an exemplary embodiment of the present invention. FIG. 10 illustratestissue (graft) 80 prior to looping it through the adjustable loop of theconstruct 50, while FIG. 11 illustrates the tissue (graft) 80 after thelooping through the adjustable loop (and over graft supporting device30) of the construct 50.

FIG. 12 illustrates the reconstruction system 100 being introduced intoa tunnel in the femoral side of the knee (usually through anarthroscopic portal). The button 20 is pulled out of the bone cortexwith the passing sutures (later discarded) and self-flips onto thecortex once tension is released on the passing suture (FIG. 13). FIG. 14illustrates the adjustable flexible loop 3 being shortened by applyingtension to the ends 1 a, 1 b of the loop 3 exiting the graft supportingdevice 30. FIGS. 14 and 15 show further tensioning of the ends 1 a, 1 bof the loop utilizing an instrument 88 (such as a suture tensioner, forexample). As the length L of the loop 3 is shortened by pulling on theends, the graft supporting device 30 is advanced further into the tunnelbetween the graft. FIG. 16 shows the graft supporting device 30 in placewithin the tunnel, separating the graft bundles, and imparting graftcompression against the tunnel walls and occluding the tunnel entrance.FIG. 17 is an enlarged view of the construct of FIG. 16. FIGS. 18 and 19illustrate additional exemplary views of the assembly 100 inserted andfixated within the femoral tunnel and the tibial tunnel.

Preferably, the graft supporting device (wedge) 30 is flush with theopening of the femoral socket and with the graft bundles separated atthe socket orifice. For this, the wedge 30 is not pulled all the wayinto the socket, but rather is positioned at the opening of the bonesocket and flush with the opening. The double bundle technique of thepresent invention facilitates strong, adjustable cortical fixation withaperture graft compression, anatomic (double bundle) graft orientationwithin a single socket, and easy graft insertion and positioning withpreloaded driver.

Femoral socket 91 (shown in FIGS. 18 and 19) may be drilledtranstibially through the medial portal or by a retrograde techniqueusing an Arthrex FlipCutter®, disclosed in U.S. Patent ApplicationPublication No. 2009/0275950. In a Medial Portal Option, for medialportal and transtibial drilling, an Arthrex RetroButton® Drill Pin maybe used. The intraosseous distance is noted by pulling back on the pinby hand, until it catches the femoral cortex. The depth marking are readon the pin closest to the femoral notch.

The femoral socket 91 is drilled to a depth about equal to the amount ofgraft desired in the femoral socket, using a low profile reamer, forexample. After creating tibial tunnel 93, the passing suture is broughtthrough tibia 94.

If using the FlipCutter®, the intraosseous length off the Drill Sleeveis read. The femur 95 is drilled (by retrograde drilling) a depth equalto the amount of graft desired in the femoral socket 91 (as detailed inthe FlipCutter® technique). After creating the tibial tunnel 93, thepassing suture is brought through the tibia 94.

As shown in FIG. 18, the double bundle construct 100 is then loaded withgraft 80 looped over the wedge 30 and positioned on driver 90 which isinserted into opening 36 of wedge 30 (FIG. 6).

The passing suture is passed through the tibia 94 and out the femur 95.The button 20 is positioned so that the nonlooped side is facinglateral. The button 20 is pulled through the femur 95 until it exits thelateral cortex to achieve fixation. This is indicated when the mark onthe loop reaches the femoral socket opening. It is important to notethat no tension should be put on the loop shortening strands until thebutton 20 has been passed, self-flips, and is fully seated against thecortex, as this could compromise graft advancement.

The marked loop shortening strands are retrieved from the implantthrough the medial portal. The graft 80 is advanced and tension ispulled on the loop shortening strands. The graft will be completelyseated when the mark on the graft reaches the femoral socket 91. Thewedge 30 is flush with the opening of the femoral socket 91 and withgraft bundles 80 a, 80 b separated, as shown in FIGS. 18 and 19. Tibialfixation is achieved by known methods in the art, for example, byemploying an interference device 40 (for example, an interference screw40) and another button 20 a (FIG. 19).

FIGS. 20-40 illustrate a method of ACL reconstruction according toanother embodiment of the present invention. In this embodiment, thetissue 80 is looped directly over the adjustable loop 3 of thebutton/loop construct 10 of the invention. FIG. 20 illustrates construct10 of FIG. 1 but with flexible ends 1 a, 1 b connected through a squareknot 1 c, for example.

Tissue (graft) 80 is looped over adjustable loop 3 as shown in FIG. 28.Loop shortening strands 1 a, 1 b of the flexible strand 1 are used tocontrol and adjust the length of the loop 3. FIG. 29 shows the button 20placed vertically at the end of the Graft Sizing Block. The implant 80is marked (a) at a distance equal to the intraosseous length from thebutton 20. The graft 80 is marked (b) at a point equal to the depth ofthe femoral socket. The first few inches of the loop shortening strands1 a, 1 b are marked (c) with a surgical marker to distinguish them fromthe rest of the implant arthroscopically.

Referring back to FIGS. 21-23, the femoral socket may be drilledtranstibially (FIG. 21) or through the medial portal (FIG. 22) or by aretrograde technique using the FlipCutter® (FIG. 23). In the medialportal option (FIGS. 24 and 25), for medial portal and transtibialdrilling, a RetroButton® Drill Pin 110 may be used. The intraosseousdistance is noted by pulling back on the pin by hand (FIG. 24), until itcatches the femoral cortex. The depth marking are read on the pinclosest to the femoral notch (FIG. 25).

The femur socket 91 is drilled to a depth about equal to the amount ofgraft desired in the femoral socket, using a Low Profile Reamer 112, forexample (FIGS. 26 and 27). After creating the tibial tunnel, the passingsuture 4 is brought through the tibia.

If using a FlipCutter 115 (FIG. 27), the intraosseous length off theDrill Sleeve is read. The femur is drilled (by retrograde drilling) adepth equal to the amount of graft desired in the femoral socket 91 (asdetailed in the FlipCutter technique). After creating the tibial tunnel93, the passing suture 4 is brought through the tibia.

Once the implant 80 has been marked (as detailed above with reference toFIGS. 28 and 29), the blue passing suture 4 is passed through the tibiaand out the femur (FIGS. 30 and 31). The button 20 is positioned so thatthe nonlooped side is facing lateral. The button 20 is pulled throughthe femur until it exits the lateral cortex to achieve fixation (FIG.31). This is indicated when the mark on the loop reaches the femoralsocket opening. No tension should be put on the loop shortening strandsuntil the button has been passed, self-flips, and is fully seatedagainst the cortex, as this could compromise graft advancement.

Referring now to FIGS. 32-34, the marked loop shortening strands 1 a, 1b are retrieved from the implant through the medial portal. The graft isadvanced and tension is pulled on the loop shortening strands. The graftwill be completely seated when the mark on the graft reaches the femoralsocket (FIG. 34).

The graft shortening strands 1 a, 1 b are pulled individually for finalgraft tensioning (FIGS. 35-37). The graft shortening strands are cutwith a cutting instrument 120 (FIG. 36) such as an arthroscopic #2FiberWire® cutter. The technique proceeds with tibial fixation.

The button/loop construct 10 of FIG. 20 (the wedgeless assembly) is alsoideal for all-inside ACL reconstruction (FIG. 38). The adjustability ofthe implant simplifies graft length determination and allows grafttensioning from the femoral side.

FIG. 39 illustrates a detailed view of the femoral graft of FIG. 38.FIG. 40 illustrates an enlarged view of the final construct of FIG. 38with tissue (graft) 80 secured within femoral socket 91 and tibia socket93 by adjustable button/loop construct 10 and an interference device 40.

The adjustable loop of the self-locking adjustable knotless construct 10is adjustable under tension when the surgeon simply pulls on both endsof the final construct 10 to adjust the length L of the flexible loopand to tighten, therefore, the construct. The button 20 is pulled out ofthe bone cortex with the passing sutures (which are later discarded) andself-flips onto the cortex immediately upon exiting.

The ACL reconstruction of the present invention offers adjustablecortical fixation for cruciate ligament reconstruction. The four-pointknotless fixation resists cyclic displacement and offers maximum loadsequal to closed loop devices. The present invention eliminates the needfor multiple sized loops and facilitates complete graft fill of shortfemoral sockets that are common with anatomic ACL drilling.

Although the embodiments above have been described with reference toparticular ACL reconstruction techniques, the invention is not limitedto these exemplary embodiments. Accordingly, the present invention alsocontemplates embodiments wherein the self-locking adjustable knotlessconstruct 10 with adjustable loop of the present invention is employedfor additional tissue positioning and/or tissue adjustment applications,for example, in fixation of bone to bone (such as small jointapplications, or acromioclavicular joint fixation techniques) whichemploy two fixation devices (for example, two buttons) joined by acontinuous suture loop. In these applications, there is no graftsupporting device but instead a second button is used in place of thegraft supporting device (wedge) 30.

In exemplary embodiments only, the self-locking adjustable knotlessconstruct 10 of the present invention may be employed in a method ofbunion repair as described in U.S. Patent Publ. No. 2008/0208252, and/orin a method of Lisfranc repair as described in U.S. Patent Publ. No.2008/0177302, the disclosures of both of which are incorporated byreference in their entirety herewith (wherein the adjustable suture loopof self-locking adjustable knotless construct 10 would be provided withan additional second button in lieu of the graft contacting device 30).Similarly, the self-locking adjustable knotless construct 10 of thepresent invention may be employed in a method of fixation of bone tobone as described in U.S. Patent Publ. No. 2007/0179531, the disclosureof which is incorporated by reference in its entirety herewith (whereinthe adjustable suture loop of self-locking adjustable knotless construct10 would be provided with an additional second button in lieu of thegraft contacting device 30, so that the adjustable loop extends betweena plurality of bone tunnels and secures at least a first bone to asecond bone).

In the above-noted exemplary embodiments, the self-locking adjustableknotless construct 10 is not provided with a graft supporting device(wedge) 30 and, instead of a wedge/plug or screw, a second button can beused (the second button may be round, oblong, and with any number ofapertures). The buttons may have a similar or different configurationand they may have at least one hole or aperture (such as button 20 withtwo apertures, or button 29 with only one aperture). The twobuttons/adjustable loop system of the present invention (comprising twobuttons with a continuous loop of flexible material having an adjustablelength and perimeter) may thus be used for syndesmosis, Lisfranc, andbunion repair, among others, with an adjustable loop construct.

While the present invention is described herein with reference toillustrative embodiments for particular applications, it should beunderstood that the invention is not limited thereto. Those havingordinary skill in the art and access to the teachings provided hereinwill recognize additional modifications, applications, embodiments andsubstitution of equivalents all fall within the scope of the invention.Accordingly, the invention is not to be considered as limited by theforegoing description.

What is claimed as new and desired to be protected by Letters Patent ofthe United States is:
 1. An ACL construct for fixation within femoraland tibial tunnels, comprising: a graft positioned at least partiallybetween first and second fixation devices; a flexible, adjustable loopof flexible material attached to the first fixation device, wherein theflexible, adjustable loop has an adjustable length to allow positioningof the graft within a femoral tunnel and a tibial tunnel, wherein theflexible, adjustable loop has two splices, wherein the flexible,adjustable loop is formed by a first adjustable eyesplice loop and asecond adjustable eyesplice loop that are interconnected at aninterconnection where the first adjustable eyesplice loop passes throughand interlocks with the second adjustable eyesplice loop, theinterconnection and the two splices being located on the opposite endsof the flexible, adjustable loop, and wherein the graft is passedthrough the flexible, adjustable loop.
 2. The ACL construct of claim 1,wherein the graft is further looped over the flexible, adjustable loopto form a double bundle construct.
 3. The ACL construct of claim 1,wherein the first fixation device is a button and the second fixationdevice is an interference device.
 4. The ACL construct of claim 3,wherein the button is adapted for engagement on the femur and is adaptedto secure the graft within the femoral tunnel, and wherein theinterference device is adapted to secure the graft within the tibialtunnel.
 5. The ACL construct of claim 1, wherein the graft is selectedfrom the group consisting of tendon, ligament, synthetic material, andbone.